MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE 4.5MM PEEK ALLTHREAD KNOTLESS ANCHOR; SCREW, FIXATION

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-03224).No device or photos were received; therefore the condition of the component is unknown.The reported event thus could not be confirmed.A device history records review was unable to be performed for this particular lot as it could not be located.A review of the complaint history determined that no further action is required.A root cause was unable to be determined.(b)(6).Concomitant devices: 4.5mm peek allthread knotless anchor part #: 904840p lot #: 534980.Product return - it is indicated that the device was discarded.

Event Description

It was reported that during a rotator cuff repair, the polymer anchor was inserted, but the desired tension could not be met.The anchor was removed and a suture anchor was used to complete the procedure without delay.

• Brand Name: 4.5MM PEEK ALLTHREAD KNOTLESS ANCHOR
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6507976
• MDR Text Key: 73329790
• Report Number: 0001825034-2017-02694
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 904840P
• Device Lot Number: 254950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 132